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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027240
Receipt No. R000031207
Scientific Title The impact of made to order exercise on exercise self efficacy and adherence among the general older adults
Date of disclosure of the study information 2017/05/31
Last modified on 2017/05/03

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Basic information
Public title The impact of made to order exercise on exercise self efficacy and adherence among the general older adults
Acronym The impact of made to order exercise on exercise self efficacy
Scientific Title The impact of made to order exercise on exercise self efficacy and adherence among the general older adults
Scientific Title:Acronym The impact of made to order exercise on exercise self efficacy
Region
Japan

Condition
Condition general older adults
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to elucidate the efficacy of the made to order exercise on exercise self-efficacy and adherence compared to traditional exercise in the general older adults who has not exercise habits
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes exercise self-efficacy score at 12-months after intervention
Key secondary outcomes 1)exercise self-efficacy score at 3 to 9-months after intervention
2)adherence
3)locomotive syndrome
4)incidence of falling
5) physical function; gait speed, gait acceleration, grip power and pain

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 prescribe the made to order exercise using automatic exercise prescription on PC software
Interventions/Control_2 prescribe the traditional exercise by simple pamphlet
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1)who aged 65 years old to 74 years when they were imformed consent
2) who are not exercise habits
3) who are gait imdependently
4) who can be assess the physical performance tests
5) who are imformed consent
Key exclusion criteria 1) who are locomotive syndrome
2) who are sarcopenia
3)who had severe comobities
4)who had a fragility fracture
5)who had a surgery for arthoroplasty
6)who had a nursing care insurance since one year
7) who had a health problems since one year
8) resarchers desided the subjects are not appropriate in this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromi Matsumoto
Organization Tottori University Hospital
Division name Rehabilitation Division
Zip code
Address Nishicho 36-1, Yonago, Tottori
TEL 0859-38-6862
Email h.matsumoto@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Wada
Organization Tottori University Hospital
Division name Rehabilitation Division
Zip code
Address Nishicho 36-1, Yonago, Tottori
TEL 0859-38-6862
Homepage URL
Email t.wada@med.tottori-u.ac.jp

Sponsor
Institute Tottori University Hospital
Institute
Department

Funding Source
Organization Tottori University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2016 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 03 Day
Last modified on
2017 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031207

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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